MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-28 for AW TRANSFER SET FOR BACT ALERT 8881225241 manufactured by Covidien.
[19283878]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a blood collection transfer set. The customer reports that the connection is loose and comes apart, spilling blood during procedures. The customer reported the female connector comes out of the safety transfer dome upon removal of the syringe. The customer stated the syringe is pulled out, while holding on to the transfer dome, and the female connector is pulled off with the syringe, exposing the needle tip. At the time of the incident, the phlebotomist received a dirty needle stick, as the device had dragged across the wrist which was holding the safety transfer dome.
Patient Sequence No: 1, Text Type: D, B5
[19516862]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2010-00014 |
| MDR Report Key | 1787760 |
| Report Source | 06 |
| Date Received | 2010-07-28 |
| Date of Report | 2010-07-16 |
| Report Date | 2010-07-16 |
| Date Reported to Mfgr | 2010-07-16 |
| Date Mfgr Received | 2010-07-16 |
| Date Added to Maude | 2011-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AW TRANSFER SET FOR BACT ALERT |
| Generic Name | BLOOD COLLECTION TRANSFER SET |
| Product Code | GJE |
| Date Received | 2010-07-28 |
| Model Number | 8881225241 |
| Catalog Number | 8881225241 |
| Lot Number | 0127459 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIB TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-28 |